Regulatory Open Forum

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  • 1.  AI SaMD

    Posted 20-Jul-2020 17:12
    Hello all,

    This question relates to Software as a medical device. This device is an AI algorithm used for triage purposes.
    Does anyone in the forum have experience with similar devices?
    Do these devices require a clinical trials as part of the performance testing?

    Appreciate any inputs or feedback from the group.

    Thank you
    Kind Regards,
    Aliva Das

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    Aliva Das
    Frisco TX
    United States
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  • 2.  RE: AI SaMD

    Posted 27-Jul-2020 11:00
    Depending on your network size, Value head, and Policy head you would require quite a bit of data for this to be accurate. Where does one acquire such data?

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    Edward Panek
    VP, QA/RA
    Blue Spark Technologies
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    Original Message


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